FDA 510(k)

PEEK Spinal Infusion Cage

K-Nummer: K223776 · 2023-03-03

AntragstellerChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.

Entscheidungsdatum2023-03-03

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

PEEK Spinal Infusion Cage is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K223776. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the PEEK Spinal Infusion Cage?

PEEK Spinal Infusion Cage is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K223776.

When did PEEK Spinal Infusion Cage receive FDA 510(k) clearance?

PEEK Spinal Infusion Cage received FDA 510(k) clearance on 2023-03-03, under 510(k) number K223776.

Who is the listed applicant for PEEK Spinal Infusion Cage?

The FDA 510(k) record lists Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEEK Spinal Infusion Cage?

The FDA product code for PEEK Spinal Infusion Cage is MAX.

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